Prospective Grant of Start-up Exclusive License: Premarket Approved Diagnostic for Identifying JC Virus, 41979 [2016-15165]
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Federal Register / Vol. 81, No. 124 / Tuesday, June 28, 2016 / Notices
Dated: June 22, 2016.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–15163 Filed 6–27–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Start-up
Exclusive License: Premarket
Approved Diagnostic for Identifying JC
Virus
National Institutes of Health.
Notice.
AGENCY:
ACTION:
This is notice, in accordance
with 35 U.S.C. 209 and 37 CFR part 404,
that the National Institute of
Neurological Disorders and Stroke
(NINDS), National Institutes of Health
(NIH), Department of Health and Human
Services, is contemplating the grant of a
start-up exclusive license to Pro Arc
Diagnostics, Inc., which is located in
Missouri, to practice the inventions
embodied in the following patents: U.S.
Patent Application 14/408,919, filed
December 17, 2014 (HHS reference E–
088–2012/0–US–03).
The patent rights in these inventions
have been assigned to the United States
of America. The prospective start-up
exclusive license territory may be
worldwide and the field of use may be
limited to FDA premarket approved
(PMA) diagnostics for the detection of
JC Virus.
DATES: Only written comments and/or
applications for a license which are
received by NINDS Technology Transfer
on or before July 13, 2016 will be
considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, comments,
and other materials relating to the
contemplated start-up exclusive license
should be directed to: Susan Ano, Ph.D.,
NINDS Technology Transfer, 31 Center
Drive, Suite 8A52, MS2540, Bethesda,
MD 20892; Telephone: (301) 435–5515;
Email: anos@mail.nih.gov.
SUPPLEMENTARY INFORMATION: This
invention provides a multiplex PCRbased method for detecting JC virus, and
distinguishing between the nonpathogenic and pathogenic JC virus that
causes progressive multifocal
leukoencephalopathy (PML) in
individuals that are
immunocompromised. The invention
helps to identify individuals at risk of
developing PML by detecting two
regions of the viral genome. The assay
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:49 Jun 27, 2016
Jkt 238001
detects JC viral DNA with high
sensitivity using the T protein coding
DNA that is highly specific and does not
allow mutations. It also detects a
genome variable region in the noncoding region that detects changes from
the nonpathogenic genotype in the urine
to the pathogenic type seen in tissues
especially in the brain, bone marrow,
plasma/serum or immune cells of PML
patients.
The prospective start-up exclusive
license may be granted unless within
fifteen (15) days from the date of this
published notice, the NIH receives
written evidence and argument that
establishes that the grant of the license
would not be consistent with the
requirements of 35 U.S.C. 209 and 37
CFR part 404.
Complete applications for a license in
the field of use filed in response to this
notice will be treated as objections to
the grant of the contemplated start-up
exclusive license. Comments and
objections submitted to this notice will
not be made available for public
inspection and, to the extent permitted
by law, will not be released under the
Freedom of Information Act, 5 U.S.C.
552.
Dated: June 21, 2016.
Susan Ano,
Technology Development Coordinator NINDS
Technology Transfer, National Institutes of
Health.
[FR Doc. 2016–15165 Filed 6–27–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health and Human
Development; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Eunice Kennedy
Shriver National Institute of Child Health
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
41979
and Human Development Special Emphasis
Panel Systematic Review of Neonatal
Medicine.
Date: August 2, 2016.
Time: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health, 6710 B
Rockledge Drive, Room 2131D, Bethesda, MD
20892 (Telephone Conference Call).
Contact Person: Sathasiva B. Kandasamy,
Ph.D., Scientific Review Officer, Division of
Scientific Review, Eunice Kennedy Shriver
National Institute of Child Health and
Human Development, NIH, 6710 B Rockledge
Drive, Room 2131D, Bethesda, MD 20892,
(301) 435–6680, skandasa@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.864, Population Research;
93.865, Research for Mothers and Children;
93.929, Center for Medical Rehabilitation
Research; 93.209, Contraception and
Infertility Loan Repayment Program, National
Institutes of Health, HHS)
Dated: June 22, 2016.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–15164 Filed 6–27–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Topics in Infectious Diseases.
Date: July 6, 2016.
Time: 2:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: John C. Pugh, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3114,
MSC 7808, Bethesda, MD 20892, (301) 435–
2398, pughjohn@csr.nih.gov.
E:\FR\FM\28JNN1.SGM
28JNN1
]]>Agencies
[Federal Register Volume 81, Number 124 (Tuesday, June 28, 2016)]
[Notices]
[Page 41979]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-15165]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Start-up Exclusive License: Premarket
Approved Diagnostic for Identifying JC Virus
AGENCY: National Institutes of Health.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This is notice, in accordance with 35 U.S.C. 209 and 37 CFR
part 404, that the National Institute of Neurological Disorders and
Stroke (NINDS), National Institutes of Health (NIH), Department of
Health and Human Services, is contemplating the grant of a start-up
exclusive license to Pro Arc Diagnostics, Inc., which is located in
Missouri, to practice the inventions embodied in the following patents:
U.S. Patent Application 14/408,919, filed December 17, 2014 (HHS
reference E-088-2012/0-US-03).
The patent rights in these inventions have been assigned to the
United States of America. The prospective start-up exclusive license
territory may be worldwide and the field of use may be limited to FDA
premarket approved (PMA) diagnostics for the detection of JC Virus.
DATES: Only written comments and/or applications for a license which
are received by NINDS Technology Transfer on or before July 13, 2016
will be considered.
ADDRESSES: Requests for copies of the patent application, inquiries,
comments, and other materials relating to the contemplated start-up
exclusive license should be directed to: Susan Ano, Ph.D., NINDS
Technology Transfer, 31 Center Drive, Suite 8A52, MS2540, Bethesda, MD
20892; Telephone: (301) 435-5515; Email: anos@mail.nih.gov.
SUPPLEMENTARY INFORMATION: This invention provides a multiplex PCR-
based method for detecting JC virus, and distinguishing between the
non-pathogenic and pathogenic JC virus that causes progressive
multifocal leukoencephalopathy (PML) in individuals that are
immunocompromised. The invention helps to identify individuals at risk
of developing PML by detecting two regions of the viral genome. The
assay detects JC viral DNA with high sensitivity using the T protein
coding DNA that is highly specific and does not allow mutations. It
also detects a genome variable region in the non-coding region that
detects changes from the nonpathogenic genotype in the urine to the
pathogenic type seen in tissues especially in the brain, bone marrow,
plasma/serum or immune cells of PML patients.
The prospective start-up exclusive license may be granted unless
within fifteen (15) days from the date of this published notice, the
NIH receives written evidence and argument that establishes that the
grant of the license would not be consistent with the requirements of
35 U.S.C. 209 and 37 CFR part 404.
Complete applications for a license in the field of use filed in
response to this notice will be treated as objections to the grant of
the contemplated start-up exclusive license. Comments and objections
submitted to this notice will not be made available for public
inspection and, to the extent permitted by law, will not be released
under the Freedom of Information Act, 5 U.S.C. 552.
Dated: June 21, 2016.
Susan Ano,
Technology Development Coordinator NINDS Technology Transfer, National
Institutes of Health.
[FR Doc. 2016-15165 Filed 6-27-16; 8:45 am]
BILLING CODE 4140-01-P
